Pharmaceutical composition

Abstract

Pharmaceutical compositions of alpha-lipoic acid and / or methylsulfonylmethane (MSM) and magnesium salts, useful for the treatment, prevention, or reduction of the severity of viral infections and / or skin diseases, are provided herein. Methods for preparing the pharmaceutical compositions and methods for using the pharmaceutical compositions in therapeutic treatments are also provided.

Description

Technical Field

[0001] Field The present invention relates to a pharmaceutical composition, particularly a pharmaceutical composition useful for the treatment or prevention of viral infections and / or skin diseases such as herpes zoster infection, varicella-zoster infection, varicella, herpes simplex, hidradenitis suppurativa, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis, and SARS-CoV-2.

Background Art

[0002] Background Acne or acne vulgaris is a disorder of the pilosebaceous follicles found on the face and upper trunk. During puberty, androgens increase the production of sebum from enlarged sebaceous glands, causing the sebaceous glands to become blocked. Propionibacterium acnes is usually involved in lesion development, but its exact role is unclear. Papules (keratinocytes with incomplete exfoliation and sebum accumulation, in an enlarged follicle) can become open comedones (blackheads) or closed comedones (whiteheads). Inflammation leads to papules, pustules, and nodules.

[0003] Nearly all teenagers are thought to experience some degree of acne during adolescence, usually mild. Moderate to severe acne develops in about 20% of young people, causing significant psychological problems and potentially gradually eroding confidence and self-esteem. There are various treatments available for acne, but these vary in their degree of success and have side effects.

[0004] Sweat gland abscesses are a long-term (chronic) skin disease. The cause is unknown, and the disease only occurs in areas of the skin that contain apocrine sweat glands. Inflammation of the areas containing apocrine sweat glands is painful and leads to recurrent suppurative lumps (boils or abscesses). Suppuration means the formation or discharge of pus. Areas such as the armpits and groin commonly leak pus and are difficult to heal. Scarring can occur. Other areas such as under the breasts, the external genitalia, scrotum, buttocks, and the skin in front of the anus (perineum) sometimes occur.

[0005] Wounds caused by boils and abscesses often do not heal completely and leave scars. In severe cases, the pus can tunnel beneath the skin's surface. These tunnels are called sinus tracts. Multiple sites of hidradenitis can be connected beneath the skin's surface by a network of interconnected sinus tracts. As a result, inflammation, and sometimes infection, can progress deeper and more extensively. The eventually healed site will be entirely covered in thick scar tissue, and the resulting scars can be as severe as the original pus-filled wounds.

[0006] Sweat gland abscesses (HS) are difficult to control with medical treatment, and the goal is to detect the disease in its early stages and treat and control the milder forms of the condition. Treatment includes the use of topical antibiotics, short-term antibiotic tablets, long-term antibiotics, retinoids, steroids, and immunomodulators such as adalimumab. Chronic HS often requires surgery in the form of incision and drainage, extensive removal (excision) of the affected area, and treatment with a carbon dioxide laser. None of these treatments are curative and can result in significant scarring requiring skin grafts and other reconstructive surgery.

[0007] High School Syndrome (HS) can interfere with normal work and social activities. Psychological problems are common, such as difficulty in having sexual relationships. These problems may be directly related to pain or discomfort from illness, or embarrassment or body image issues.

[0008] Psoriasis is a chronic inflammatory skin disease that manifests as erythematous, dry, scaly patches caused by hyperkeratosis. While the patches most commonly appear on the elbows, knees, and scalp, more extensive lesions can occur in other parts of the body, particularly the lumbosacral region. The most common treatment for mild to moderate psoriasis involves topical application of compositions containing corticosteroids as the active ingredient. Although effective, topical corticosteroid application has many drawbacks, including skin atrophy, striae, acneiform rashes, perioral dermatitis, overgrowth of fungi and bacteria on the skin, loss of natural skin color, and rosacea.

[0009] Shingles, also known as herpes zoster, is a disease that can cause lesions on the skin such as painful rashes, redness, and / or fluid-filled blisters. Symptoms may include itching, tingling, or burning at the site of the infection, as well as fever, chills, headache, and stomach upset. Postherpetic neuralgia is a common complication of herpes zoster, often affecting the skin and / or nerve fibers and causing persistent pain after other symptoms have subsided. Shingles is caused by the varicella-zoster virus, which also causes other diseases such as chickenpox. Ocular shingles is a type of herpes zoster infection that develops in the ocular region (V1) of the trigeminal nerve, which can lead to further complications such as eye disease, neuropathy, and / or migraines. There are several treatment options, including antiviral drugs such as acyclovir, famciclovir, and valacyclovir, but the need for further treatment for shingles and related disorders remains.

[0010] Atopic dermatitis / eczema is a disease characterized by itching and / or redness of the skin. Often, the disease tends to recur periodically. Symptoms may include dry, itchy skin, red to brownish-gray patches, raised skin, and thickened, cracked, swollen, or ulcerated skin. Atopic dermatitis / eczema can be associated with other illnesses, such as viral infections. For example, viruses and other pathogens can readily infect the skin of some patients with atopic dermatitis and worsen the condition.

[0011] For example, it would be desirable to provide treatments for viral infections and / or skin diseases such as herpes zoster, varicella-zoster infection, herpes simplex infection, chickenpox, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis, and SARS-CoV-2. [Overview of the Initiative] [Means for solving the problem]

[0012] overview The inventors of the present invention have identified a pharmaceutical composition that has unexpected efficacy in treating diseases and / or skin diseases associated with various viral infections.

[0013] Therefore, a pharmaceutical composition comprising (a) a magnesium salt and (b) lipoic acid and / or methylsulfonylmethane (MSM) is provided.

[0014] In some embodiments, the magnesium salt is selected from the group consisting of magnesium chloride and magnesium sulfate.

[0015] In some embodiments, the composition is formulated for topical administration.

[0016] In some embodiments, the composition comprises magnesium chloride, alpha-lipoic acid, and methylsulfonylmethane (MSM).

[0017] In some embodiments, the composition further comprises sodium bicarbonate.

[0018] In some embodiments, the composition comprises a emollient, a wetting agent, an emulsifier, or a preservative, or a mixture thereof.

[0019] In some embodiments, i) The emollient is selected from the group consisting of glyceryl stearate, ceteareth-20, ceteareth-12, cetearyl alcohol, cetyl palmitate, dimethicone, cyclopentasiloxane, cyclohexasiloxane, and caprylic / capric triglyceride or mixtures thereof; ii) The wetting agent is selected from the group consisting of glycerol, glycerin, salicylic acid, and sorbitol or mixtures thereof; ii) The emulsifier is selected from the group consisting of glyceryl stearate, ceteareth-20, ceteareth-12, cetearyl alcohol and cetyl palmitate or mixtures thereof; and iii) The preservative is selected from the group consisting of phenoxyethanol, ethylhexylglycerin, and sodium benzoate or a mixture thereof.

[0020] In some embodiments, the composition is in the form of a liquid, aqueous solution, gel, suspension, emulsion, ointment, or cream.

[0021] In some embodiments, the composition comprises, based on the weight of the composition, 10% to 65% magnesium sulfate, 5% to 20% MSM, 5% to 35% magnesium chloride, 1% to 10% sodium bicarbonate, and / or 0.1% to 1% alpha-lipoic acid.

[0022] In some embodiments, the composition comprises, based on the weight of the composition, 20% to 50% magnesium chloride, alpha-lipoic acid, sodium bicarbonate, magnesium sulfate, and methylsulfonylmethane (MSM).

[0023] In some embodiments, the composition includes lemon extract.

[0024] In some embodiments, the composition contains 50% to 80% by weight of lemon extract.

[0025] A method for treating, preventing or reducing the severity of a viral infection or a disease or disorder associated with a viral infection or symptoms of a viral infection or symptoms of a disease or disorder associated with a viral infection in a subject, the method comprising administering to the subject an effective amount of the pharmaceutical composition disclosed herein, is also provided.

[0026] In some embodiments, the viral infection or the disease or disorder associated with the viral infection is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, chickenpox, shingles, oral herpes, genital herpes, hidradenitis suppurativa, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia and SARS-CoV-2.

[0027] In some embodiments, the symptoms are selected from the group consisting of cracked skin, skin bleeding, skin peeling, skin redness and pain.

[0028] A method for treating, preventing or reducing the severity of a disease or disorder or symptoms of a disease or disorder in a subject, the disease or disorder being selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, chickenpox, shingles, oral herpes, genital herpes, hidradenitis suppurativa, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis and SARS-CoV-2, the method comprising administering to the subject an effective amount of the pharmaceutical composition disclosed herein, is also provided.

[0029] In some embodiments, the composition is administered topically to the subject.

[0030] In some embodiments, the composition is applied to the skin of the subject once daily, twice daily or three times daily.

[0031] In some embodiments, the topical composition is applied once daily.

[0032] In some embodiments, the composition is applied as a spray, cream or liquid.

[0033] In some embodiments, the composition is administered to the subject by inhalation.

[0034] The use of the pharmaceutical compositions disclosed herein for the manufacture of a medicament for treating, preventing, or reducing the severity of a viral infection or a disease or disorder associated with a viral infection, or symptoms of a viral infection or symptoms of a disease or disorder associated with a viral infection.

[0035] In some embodiments, the viral infection or disease or disorder associated with a viral infection is selected from the group consisting of herpes zoster infection, varicella-zoster infection, varicella, herpes zoster, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, and postherpetic neuralgia.

[0036] In some embodiments, the symptoms are selected from the group consisting of cracked skin, skin bleeding, skin peeling, skin redness, and pain.

[0037] Uses of pharmaceutical compositions disclosed herein for the manufacture of a medicament for treating, preventing or reducing the severity of a disease or disorder or the symptoms of a disease or disorder, wherein the disease or disorder is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis, and SARS-CoV-2.

[0038] In some embodiments, the composition is administered topically.

[0039] In some embodiments, the composition is applied to the target skin once, twice, or three times daily.

[0040] In some embodiments, the topical composition is applied once a day.

[0041] In some embodiments, the composition is applied as a spray, cream, or liquid.

[0042] In some embodiments, the composition is administered to the subject by inhalation.

[0043] Pharmaceutical compositions disclosed herein are also provided for use in treating, preventing, or reducing the severity of viral infections or diseases or disorders associated with viral infections, or symptoms of viral infections or symptoms of diseases or disorders associated with viral infections.

[0044] In some embodiments, the viral infection or disease or disorder associated with a viral infection is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, and SARS-CoV-2.

[0045] In some embodiments, the symptoms are selected from the group consisting of cracked skin, skin bleeding, skin peeling, skin redness, and pain.

[0046] Pharmaceutical compositions disclosed herein for use in treating, preventing or reducing the severity of a disease or disorder or its symptoms, wherein the disease or disorder is selected from the group consisting of herpes zoster infection, varicella-zoster infection, varicella, herpes zoster, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, pulmonary fibrosis, and postherpetic neuralgia.

[0047] In some embodiments, the composition is administered topically.

[0048] In some embodiments, the composition is applied to the target skin once, twice, or three times daily.

[0049] In some embodiments, the topical composition is applied once a day.

[0050] In some embodiments, the composition is applied as a spray, cream, or liquid.

[0051] In some embodiments, the composition is administered to the subject by inhalation.

[0052] Pharmaceutical compositions disclosed herein are also provided for use in treating, preventing, or reducing the severity of viral infections or diseases or disorders associated with viral infections, or symptoms of viral infections or symptoms of diseases or disorders associated with viral infections.

[0053] In some embodiments, the viral infection or disease or disorder associated with a viral infection is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, and SARS-CoV-2.

[0054] In some embodiments, the symptoms are selected from the group consisting of cracked skin, skin bleeding, skin peeling, skin redness, and pain.

[0055] Also provided are pharmaceutical compositions disclosed herein for use in treating, preventing or reducing the severity of a disease or disorder or its symptoms, wherein the disease or disorder is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis, and SARS-CoV-2.

[0056] In some embodiments, the composition is administered topically.

[0057] In some embodiments, the composition is applied to the target skin once, twice, or three times daily.

[0058] In some embodiments, the topical composition is applied once a day.

[0059] In some embodiments, the composition is applied as a spray, cream, or liquid.

[0060] In some embodiments, the composition is administered to a subject by inhalation. A method for preparing a pharmaceutical composition disclosed herein, Combining methylsulfonylmethane (MSM) and / or alpha-lipoic acid with magnesium salts to form a mixture, and A method is also provided which involves combining a mixture with water or an aqueous solution.

[0061] In some embodiments, the method is (i) Combining magnesium sulfate, methylsulfonylmethane (MSM), alpha-lipoic acid, and sodium bicarbonate, (ii) Add magnesium chloride to the product of step (i) in order to form a mixture. (iii) The mixture formed in step (ii) is combined with water or an aqueous solution.

[0062] In some embodiments, the method comprises step (iv), in which the aqueous mixture of step (iii) is then heated to about 60°C to about 90°C and mixed until homogeneous with one or more emulsifiers and oil phase components.

[0063] In some embodiments, the mixture formed in step (iv) comprises, on a weight basis, 10% to 65% magnesium sulfate, 5% to 20% MSM, 5% to 35% magnesium chloride, 1% to 10% sodium bicarbonate, and 0.1% to 1% alpha-lipoic acid.

[0064] In some embodiments, the pharmaceutical composition comprises, based on the weight of the composition, 20% to 50% magnesium chloride, alpha-lipoic acid, sodium bicarbonate, magnesium sulfate, and methylsulfonylmethane (MSM), and 50% to 80% by weight of water or aqueous solution.

[0065] In some embodiments, an aqueous solution is added, and the aqueous solution contains lemon extract.

[0066] In some embodiments, the lemon extract is lemon juice. [Brief explanation of the drawing]

[0067] Brief explanation of the drawing [Figure 1A] Figure 1 shows the treatment of a patient with a sweat gland abscess using a topical composition. Figure 1A shows a photograph of the patient's face before treatment with the topical composition, showing signs of stage I HS. [Figure 1B] Figure 1B shows a photograph taken three weeks after applying the topical composition to the affected skin, illustrating the reduction in visual signs of HS. [Figure 2A] Figure 2 shows the treatment of a patient with herpes zoster (shingles) using a topical composition. Figure 2A shows a photograph of the patient's leg before treatment with the topical composition, showing signs of herpes zoster. [Figure 2B] Figure 2B shows a photograph of a patient's leg before treatment with a topical composition, illustrating the signs of herpes zoster. [Figure 2C] Figure 2C shows a photograph taken three days after applying the topical composition to the affected skin, illustrating a reduction in the visual signs of herpes zoster. [Figure 2D] Figure 2D shows a photograph taken three days after applying the topical composition to the affected skin, illustrating a reduction in the visual signs of herpes zoster. [Figure 3A] Figure 3 shows the treatment of a patient with herpes zoster using a topical composition. Figure 3A shows a photograph of the patient's neck at the time of the first treatment with the topical composition, showing signs of herpes zoster. [Figure 3B]Figure 3B shows a photograph taken after applying the topical composition to affected skin, illustrating a reduction in the visual signs of herpes zoster. [Figure 4A] Figure 4 shows the treatment of atopic dermatitis patients with topical compositions. Figure 4A shows a photograph of a patient's hand immediately after treatment with the topical composition. [Figure 4B] Figure 4B shows a photograph of a patient's hand immediately after treatment with the topical composition. [Modes for carrying out the invention]

[0068] Detailed explanation General Techniques and Definitions As is clear, preferred features and characteristics of one aspect of the present invention are applicable to many other aspects of the present invention.

[0069] Throughout this specification, variations of the word “comprise,” “comprises,” or “comprising” shall be understood to imply the inclusion of the described element, integer, or step, or group of elements, integers, or steps, but not to exclude any other element, integer, or step, or group of elements, integers, or steps.

[0070] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art (e.g., in molecular genetics, biochemistry, and immunology).

[0071] Concentration, volume, solubility, and other numerical data may be expressed in range form as herein. Such range forms are used solely for convenience and brevity, and should be understood to be flexibly interpreted to include not only the numerical values ​​explicitly detailed as limits of the range, but also all individual numerical values ​​or subranges contained within that range, as if each numerical value and subrange were explicitly detailed. All digits representing quantities, percentages, or proportions and other numerical values ​​used herein should be understood in all cases to be modified by the term “approximately”.

[0072] A “topical composition” is a composition comprising a pharmaceutical composition suitable for application to the skin, as described herein. A “topical composition” may be advantageous in that it avoids first-pass metabolism and gastrointestinal absorption, can enable the delivery of active ingredients with a relatively short biological half-life and / or narrow therapeutic area, and can enable the delivery of active ingredients to a local area of ​​the skin.

[0073] As used throughout, "subject" means either an animal or a human. Therefore, in one aspect, the subject is a primate or a mammal such as a human patient.

[0074] The terms “to treat,” “to be treated,” or “to treat” as used herein refer to therapeutic procedures and / or preventive or protective measures, the purpose of which is to prevent, reduce, eliminate or delay (alleviate) an undesirable physiological disease, disorder or illness, or to obtain a beneficial or desired clinical outcome (e.g., to reduce the signs or symptoms of acne, sweat gland abscess or psoriasis). For the purposes of this disclosure, beneficial or desired clinical outcomes include, but are not limited to, relief of symptoms; reduction of the severity of a disease, disorder or illness; stabilization (i.e., no worsening) of the disease, disorder or illness; delay of the onset or progression of a disease, disorder or illness; recovery of the disease, disorder or illness; and remission (whether partial or complete), whether detectable or undetectable, or improvement or improvement of a disease, disorder or illness. Treatment includes inducing a clinically significant response without excessive levels of undesirable side effects.

[0075] The term “prevention” means, as used herein, protecting a subject from developing at least one symptom of acne, hidradenitis suppurativa, or psoriasis, or reducing the severity of symptoms of acne, hidradenitis suppurativa, or psoriasis.

[0076] The terms “apply,” “apply,” and / or “apply” refer to bringing a topical composition into contact with the skin surface of a mammal, preferably a human patient, as used herein with respect to the composition.

[0077] As used herein, the term “pharmaceutically acceptable” and its grammatical variations refer to materials used in the final composition that are non-irritating or harmful to patients in general, particularly to the skin, and preferably well-tolerated, as they refer to carriers, diluents, excipients, and reagents or other components of the composition.

[0078] The term “dermatologically acceptable” means, as used herein, a composition or component thereof that can be used in contact with mammalian skin tissue without excessive toxicity, incompatibility, instability, allergic reactions, and other similar effects. The term “dermatologically acceptable carrier” means, as used herein, a carrier that is suitable for topical application to keratinous tissue, has acceptable aesthetic properties, is compatible with the active compound, does not cause any safety or toxicity concerns, and / or is approved by regulatory authorities or is listed in a pharmacopoeia or other handbook generally accepted for use in animals, more specifically in humans.

[0079] Those skilled in the art will understand that the topical compositions described herein will typically contain a “therapeutic effective dose” or “effective dose” of an ingredient. The terms “therapeutic effective dose” or “effective dose” are used herein to mean an amount of an active ingredient sufficient to produce a therapeutic effect at the time of administration, for example, an amount that, when repeatedly applied to the affected site over a period of time, would cause improvement or change in the disease being treated. The effective dose will vary depending on the specific disease being treated, the severity of the disease, the duration of treatment, the stage of disease progression, the affected body surface area with clinical condition, and the specific components of the composition. The effective dose of an active ingredient for the treatment of a disease or disorder can be determined by standard clinical techniques. In any given case, the appropriate amount will be immediately apparent to those skilled in the art considering this disclosure or can be determined by routine experimentation. The compositions are generally applied topically to the affected site, i.e., topically to areas of skin with significant clinical abnormalities.

[0080] composition The inventors of the present invention have determined that a composition comprising one or more magnesium salts, such as magnesium chloride or magnesium sulfate, in combination with one or more organosulfur compounds, such as lipoic acid or methylsulfonylmethane (MSM), formulated for topical application, can be used to treat and / or prevent viral infections and skin diseases such as herpes zoster, varicella-zoster infection, varicella, herpes zoster, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, and postherpetic neuralgia.

[0081] Any suitable magnesium salt may be used, for example, magnesium chloride, magnesium sulfate, or a mixture thereof. In some embodiments, the composition contains magnesium sulfate heptahydrate. In some embodiments, the composition contains magnesium chloride hexahydrate. In some embodiments, the composition contains both magnesium sulfate heptahydrate and magnesium chloride hexahydrate.

[0082] In some embodiments, the composition contains magnesium sulfate heptahydrate in an amount ranging from 10 to 65% by weight or 45 to 65% by weight.

[0083] In some embodiments, the composition contains magnesium chloride in an amount ranging from 5 to 35% by weight or 20 to 35% by weight.

[0084] In some embodiments, the composition contains alpha-lipoic acid in an amount ranging from 0.1 to 1% by weight.

[0085] In some embodiments, the composition contains methylsulfonylmethane in an amount ranging from 10 to 20% by weight. Methylsulfonylmethane is also known as dimethyl sulfone.

[0086] In some embodiments, the composition comprises magnesium chloride, alpha-lipoic acid, and methylsulfonylmethane (MSM).

[0087] In some embodiments, the composition comprises magnesium chloride, magnesium sulfate (e.g., magnesium sulfate heptahydrate), alpha-lipoic acid, and methylsulfonylmethane (MSM).

[0088] In some embodiments, the composition includes a buffer. In some embodiments, the composition includes a base.

[0089] In some embodiments, the composition includes a bicarbonate or carbonate, such as sodium bicarbonate.

[0090] In some embodiments, the composition includes lemon extract, such as lemon juice. In some embodiments, the composition includes 50% to 80% by weight of lemon extract.

[0091] In some embodiments, the composition comprises (a) magnesium chloride and / or magnesium sulfate and (b) lipoic acid and / or methylsulfonylmethane (MSM) dissolved / suspended in water or another suitable aqueous solvent. In another embodiment, the topical composition further comprises one or more of sodium bicarbonate and lemon extract.

[0092] In some embodiments, the composition comprises (a) magnesium chloride and / or magnesium sulfate and (b) lipoic acid and / or methylsulfonylmethane, water or another aqueous solvent and one or more oil phase components.

[0093] In some embodiments, the composition contains betel vegetative leaf oil.

[0094] In some embodiments, the composition includes a surfactant such as polysorbate 20.

[0095] In some embodiments, the composition comprises betel vegetarian (Piper Betle) leaf oil and polysorbate 20.

[0096] In some embodiments, the composition includes gum, such as xanthan gum. In some embodiments, the composition comprises, based on the dry weight of the composition, 45% to 65% magnesium sulfate, 10% to 20% MSM, 20% to 35% magnesium chloride, 1% to 10% sodium bicarbonate, and / or 0.1% to 1% alpha-lipoic acid.

[0097] In some embodiments, the composition comprises, based on the weight of the composition, 10% to 65% magnesium sulfate, 5% to 20% MSM, 5% to 35% magnesium chloride, 1% to 10% sodium bicarbonate, and / or 0.1% to 1% alpha-lipoic acid.

[0098] In some embodiments, the composition comprises, based on the weight of the composition, 20% to 50% magnesium chloride, alpha-lipoic acid, sodium bicarbonate, magnesium sulfate, and methylsulfonylmethane (MSM).

[0099] In some embodiments, the composition comprises magnesium chloride, magnesium sulfate, methylsulfonylmethane (MSM), alpha-lipoic acid, sodium bicarbonate, and xanthan gum.

[0100] In some embodiments, the composition comprises 51% w / w magnesium sulfate heptahydrate, 26.2% w / w magnesium chloride hexahydrate, 15.7% w / w methylsulfonylmethane, and 0.5% alpha-lipoic acid.

[0101] In some embodiments, the composition comprises 18-22% w / w magnesium sulfate hexahydrate, 8-12% w / w magnesium chloride hexahydrate, 0.5-2% w / w methylsulfonylmethane, and 0.1-0.3% w / w alpha-lipoic acid.

[0102] In some embodiments, the composition is provided in the form of an aqueous solution.

[0103] In some embodiments, the composition is an aqueous solution containing magnesium chloride, magnesium sulfate, methylsulfonylmethane (MSM), alpha-lipoic acid, and sodium bicarbonate.

[0104] In some embodiments, the composition is an aqueous solution containing magnesium chloride hexahydrate, magnesium sulfate heptahydrate, methylsulfonylmethane (MSM), alpha-lipoic acid, and sodium bicarbonate.

[0105] In some embodiments, the composition is a 50 ml aqueous solution containing magnesium chloride hexahydrate (7.85 g), magnesium sulfate heptahydrate (15.31 g), methylsulfonylmethane (MSM) (4.71 g), alpha-lipoic acid (0.16 g), and sodium bicarbonate.

[0106] In some embodiments, two packets containing a total net weight of 30 g of powder are given. Powder mix A contains the following components: magnesium sulfate heptahydrate (15.31 g), magnesium chloride hexahydrate (7.85 g), dimethyl sulfone (4.71 g), and alpha-lipoic acid (0.16 g). Powder B contains the following: sodium bicarbonate. The packets containing the powders are to be combined with water to make a 50 mL solution.

[0107] In some embodiments, the composition is formulated for topical administration.

[0108] The compositions of the present disclosure can be formulated by those skilled in the art, for example, as liquids, lotions, aqueous solutions, sprays, emulsions, moisturizers, sunscreens, creams, lotions, masks, suspensions, powders, gels, jellies, pastes, foams, ointments, creams, adhesives, serums, treated cloths or pads, and other similar materials.

[0109] In some embodiments, the composition may be applied to the skin by any means known in the art, including but not limited to aerosols, sprays, pump-packs, brushes, cotton swabs, or other applicators. Optionally, the applicator may provide a fixed or variable amount of application, such as a metered aerosol, an energy-storage metered pump, or a manual metered pump.

[0110] In some embodiments, the compositions described herein are aqueous solutions. The pharmaceutical compositions may contain, for example, about 50% to about 99.9% by weight or about 70% to about 99.9% by weight of water. Appropriately, the pH of the composition is adjusted to a pH between about 2 and about 6, but preferably to a pH between about 4 and about 6, such as about 4.5 to about 5.5. The aqueous solution may also contain one or more of the cosolvents, wetting agents, chelating agents, antioxidants, preservatives, fragrances, colorants, or penetration enhancers well known in the art. The aqueous solution may be applied to the skin using any suitable technique, and in one embodiment, it is applied as a spray.

[0111] In some embodiments, the compositions described herein are aqueous gels. In these embodiments, the pharmaceutical composition contains water in an amount of about 50% to about 99% by weight, such as about 70% to about 99% by weight. Preferably, the pH of the composition is adjusted to a pH between about 2 and about 6, but more specifically to a pH between about 4 and about 6 or about 4.5 to about 5.5. For pH adjustment, any active agent commonly used in laboratories for pH adjustment, such as hydrochloric acid or sodium hydroxide, can be used. Other acids, such as acetic acid, benzoic acid, formic acid, fumaric acid, lactic acid, phosphoric acid, sulfuric acid, or other organic and / or inorganic acids, which are well known to those skilled in the art, can also be used. Other bases, such as ammonium hydroxide, ethanolamine, magnesium hydroxide, sodium or potassium bicarbonate, sodium or potassium hydroxide, or organic and / or inorganic bases, which are well known to those skilled in the art, can also be used. Furthermore, in these embodiments, the pharmaceutical composition also includes a suitable gelling agent. The composition may further contain a cosolvent, a wetting agent, a chelating agent, an antioxidant, a preservative, a fragrance, a coloring agent, or a penetration enhancer, or a combination or mixture thereof.

[0112] In another embodiment, the dermatologically acceptable formulation is a cream. In one embodiment, the cream is an oil-in-water cream. Preferably, the oil-in-water cream comprises an oil phase, an aqueous phase, a surfactant, and an antioxidant.

[0113] In some embodiments, the composition is formulated as an emulsion. In some embodiments, the emulsion contains an emulsifier, such as glyceryl stearate, ceteareth-20, ceteareth-12, cetearyl alcohol, cetyl palmitate, or a mixture thereof.

[0114] In some embodiments, a dermatologically acceptable formulation comprises one or more emollients and / or humectants. Suitable emollients and humectants for the composition include glycerol, glyceryl stearate, ceteareth-20, ceteareth-12, cetearyl alcohol, cetyl palmitate, dimethicone, cyclopentasiloxane, cyclohexasiloxane, caprylic / capric triglyceride, or mixtures thereof.

[0115] In some embodiments, dermatologically acceptable formulations include one or more preservatives. Suitable preservatives for the composition include phenoxyethanol, ethylhexylglycerin, sodium benzoate, potassium sorbate, sorbic acid, methylparaben, or mixtures thereof.

[0116] In the embodiments described herein, an adhesive is added to the topical composition to increase viscosity, enabling the topical composition to adhere to a surface, or to improve the feel of the composition on a person when using or applying the composition. In the embodiments described herein, a thickener is added to the topical composition to stabilize the dispersion until use. In the embodiments described herein, the adhesives used include cellulose compounds such as cetearyl alcohol, carrageenan, methylcellulose, hydroxymethylcellulose, acrylamide / acryloyldimethyltaurate sodium copolymer and carboxymethylcellulose; pectin; dextran in various molecular weight ranges; starch; tragacanth gum; acacia gum; gar gum; acacia gum; karaya gum; silica, diatomaceous earth; and other commonly used working substances well known to those skilled in the art. In the embodiments described herein, the approximate range of added adhesive is from about 0.001% to about 10%.

[0117] In the embodiments described herein, other components such as preservatives, colorants, and fragrances may be added to the topical composition, but are not limited to these. Examples of preservatives include phenoxyethanol, ethylhexylglycerin, butylhydroxyanisole ("BHA"), butylhydroxytoluene ("BHT"), phenols, resorcinol; parabens such as methylparaben, ethylparaben, propylparaben, butylparaben, isopropylparaben, and isobutylparaben; 2-phenoxyethanol, 1,3-octanediol; sodium benzoate, benzyl alcohol, or other preservatives commonly used in industry. Other phenolic active ingredients include 4,6-di-tert-butylresorcinol, 2,6-di-tert-butylphenol, 2,5-di-tert-butylphenol, 3,5-di-tert-butylphenol, 2,6-di-tert-hexylphenol, 2,6-di-tert-octylphenol, and 2,6-di-tert-decylphenol. The general range for adding preservatives is approximately 0.01% to 10% by weight of the composition.

[0118] In the embodiments described herein, fragrances are added to the composition. The fragrance is added to the composition in an amount ranging from about 0.001% to about 20%. Examples of fragrances that may be used are, but are not limited to, ammonium glycyrrhizinate, amyl acetate, anisaldehyde, benzoic acid, birch extract, caraway fruit oil, safflower seed oil, caramel, cedarwood oil, cinnamyl acetate, citrus extracts derived from orange, grapefruit, lemon or lime, citrus, corngrass, carrot, clove, eucalyptus, wintergreen, licorice, lavender, cherry, various berries or other similar substances.

[0119] In some embodiments, the composition comprises a pharmaceutically and / or dermatologically acceptable excipient comprising components selected from: polysaccharide polymers, glycerin, glycerol, butylene glycol, dipropylene glycol, pentylene glycol, polyethylene glycol, ethanol, and water. In embodiments described herein, the pharmaceutically and / or dermatologically acceptable excipient may comprise one or more cosmetically or pharmaceutically acceptable carriers. Suitable carriers that may be used in the topical compositions described herein are well known in the art and include, but are not limited to, solubilizers such as C2-C8 linear and branched alcohols, diols and triols; moisturizers and wetting agents such as glycerin, glycerol, amino acids and amino acid derivatives, polyamino acids and derivatives, pyrrolidone carboxylic acids and their salts and derivatives; surfactants such as sodium laureth sulfate and sorbitan monolaurate; emulsifiers such as cetyl alcohol, stearyl alcohol, glyceryl stearate, ceteareth-20, ceteareth-12, cetearyl alcohol, cetyl palmitate or mixtures thereof; emollients such as dimethicone, cyclopentasiloxane, cyclohexasiloxane, caprylic / capric triglyceride, lanolin, mineral oil, petrolatum, and cetyl alcohol; and thickeners such as xanthan gum, methylcellulose, ethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, polyvinylpyrrolidone, polyvinyl alcohol, and acrylic polymers. Other examples of suitable excipients, such as binders and volume extenders, are listed in Remington's Pharmaceutical Sciences (18th Edition, Ed. Alfonso Gennaro, Mack Publishing Co. Easton, Pa., 1995) and Handbook of Pharmaceutical Excipients (3rd Edition, Ed. Arthur H. Kibbe, American Pharmaceutical Association, Washington, DC 2000). In one embodiment, the composition comprises xanthan gum.

[0120] In some embodiments, the composition may include one or more additional activators and / or therapeutic agents, for example, activators and / or therapeutic agents useful in treating viral diseases and / or skin diseases, such as active ingredients useful in treating diseases such as herpes zoster, varicella-zoster infection, chickenpox, herpes zoster, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema and / or postherpetic neuralgia.

[0121] In some embodiments, the pharmaceutical composition is intended to be administered in combination with further therapeutic agents and / or activators.

[0122] In some embodiments, further therapeutic agents are antiviral agents, antibiotics, disinfectants, antibacterial agents, antimicrobial agents, analgesics, or anti-inflammatory agents. In additional embodiments, the topical compositions of the present invention may further include anesthetics, anti-acne agents, humectants such as cationic, ionic, and nonionic surfactants, moisturizers, antipruritics, antiperspirants, antipsoriatic agents, anti-seborrheic agents, anti-aging and anti-wrinkle agents, skin whitening agents, depigmentants, and vitamins.

[0123] Examples of antiviral drugs include, but are not limited to, penciclovir, acyclovir, cidofovir, idoxuridine, edoxudine, caffeine, trifluorothymidine, nonoxynol-9, glutaraldehyde, povidone-iodine, and ascorbic acid.

[0124] Exemplary antibiotics include ampicillin, bacampicillin, carbenicillin indanil, mezlocillin, piperacillin, ticarcillin, amoxicillin-clavulanate, ampicillin-sulbactam, benzylpenicillin, cloxacillin, dicloxacillin, methicillin, oxacillin, penicillin G, penicillin V, piperacillin tazobactam, ticarcillin-clavulanate, nafcillin, procainepenicillin, cefadroxil, cefazolin, cephalexin, cephalothin, cefapillin, cefazolin, cefaclor, cefamandol, cefonisid, cefotetan, cefoxitin, cefprodil, cefmetazole, cefuroxime, loracalbef, cefdinir, ceftibutene, cef This includes, but is not limited to, operazone, cefixime, cefotaxime, cefpodoxime proxetil, ceftazidime, ceftizoxime, ceftriaxone, cefepime, azithromycin, clarithromycin, clindamycin, zilithromycin, erythromycin, lincomycin, troleandomycin, cinoxacin, ciprofloxacin, enoxacin, gatifloxacin, glepafloxacin, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, sparfloxacin, trovafloxacin, oxolinic acid, gemifloxacin, pefloxacin, imipenem-cilastatin, meropenem, and aztreonam. In one embodiment, the amount of antibiotic in the composition is 0.01 to 5% by weight of the total composition.

[0125] The disinfectant compounds include, but are not limited to, iodine, manuka honey, octenidine dihydrochloride, phenol, polyhexanide, sodium chloride, sodium hypochlorite, calcium hypochlorite, sodium bicarbonate, methylparaben, and sodium dehydroacetate. In one embodiment, the amount of the disinfectant compound in the topical formulation is 0.01 to 5% by weight of the total composition.

[0126] Antimicrobial agents include, but are not limited to, amphotericin B, candicidine, philipin, hamycin, natamycin, nystatin, rimocidine, bifonazole, butoconazole, clotrimazole, econazole, fenticonazole, isoconazole, ketoconazole, luliconazole, miconazole, omoconazole, oxyconazole, sertaconazole, sulconazole, thioconazole, albaconazole, fluconazole, isabconazole, itraconazole, posaconazole, ravconazole, terconazole, voriconazole, abafungin, amorolfine, butenafine, naftifine, terbinafine, anidurafungin, caspofungin, micafungin, benzoic acid, cyclopirox, flucytosine, griseofulvin, haloprogin, tolnaftate, undecylenic acid, crystal violet, and peruvian balsam. In one embodiment, the amount of antibacterial agent in the topical formulation is 0.01 to 5% by weight of the total composition.

[0127] The analgesics include, but are not limited to, methyl salicylate, codeine, morphine, methadone, pethidine, buprenorphine, hydromorphine, levorphanol, oxycodone, fentanyl, and nonsteroidal anti-inflammatory drugs. The amount of analgesics in the topical preparation is 0.01 to 5% by weight of the total composition.

[0128] In some embodiments, the composition does not contain any further activators or therapeutic agents.

[0129] In some embodiments described herein, the compositions are topical compositions. In some embodiments, the compositions include secondary skincare active substances. The term “skincare active substance” refers to a compound or substance that provides benefits when applied to the skin. Skincare active substances may provide benefits or claimed benefits in areas such as wrinkle removal or reduction, skin tightening, skin exfoliation, acne treatment, skin conditioning, improvement of skin barrier properties, sweat control, anti-aging, reduction or avoidance of irritation, and reduction or avoidance of inflammation. Examples of skincare active substances include molecules such as peptides, proteins, oligonucleotides, and fullerenes, as well as small molecules. Skincare active substances may include protease and / or enzyme inhibitors, anticoenzymes, chelating agents, antibodies, antimicrobials, humectants, vitamins, skin protectants, antioxidants and / or skin soothing agents, plant extracts, and other similar substances. Examples of skincare active substances include, but are not limited to, vitamin C, vitamin E (alpha-tocopherol), retinoids, soy derivatives (e.g., isoflavones), green tea polyphenols, alpha hydroxy acids (e.g., glycolic acid and lactic acid), beta hydroxy acids (e.g., salicylic acid), polyhydroxy acids, alpha-lipoic acid, hemp oil (glycerides), niacinamide, dimethylaminoethanol, coenzyme Q10, capryloyl glycine, undecylenoyl glycine, octenidine HCl, elubiol, 1,2-hexanediol, oligopeptide-10, bakuchiol, 4-hydroxycyclohexanecarboxylate butyl ester, black cumin oil, cinnamon extract, quercetin, ECGC, blueberry extract, resveratrol and pterostilbene, beta-glucan, kinetin (plant growth hormone), dimethyl sulfone, and botulinum toxin. Another example of a skincare active ingredient can be found in *The Perricone Prescription* (Nicholas Perricone, Harper Collins Publishers Inc., New York, 2002).

[0130] Manufacturing of the composition A method for preparing a pharmaceutical composition disclosed herein is also provided, comprising combining methylsulfonylmethane (MSM) and / or alpha-lipoic acid with a magnesium salt to form a mixture, and combining the mixture with water or an aqueous solution.

[0131] For example, compositions according to this disclosure may be prepared as follows: dry components (e.g., magnesium sulfate, methylsulfonylmethane (MSM), alpha-lipoic acid, and sodium bicarbonate) are mixed together and then subsequently dissolved / suspended in a suitable aqueous solvent. The aqueous solvent may be, for example, water, a buffered aqueous solution, and / or lemon extract.

[0132] In some embodiments, the method comprises (i) combining magnesium sulfate, methylsulfonylmethane (MSM), alpha-lipoic acid, and sodium bicarbonate to form a dry component mixture; (ii) adding magnesium chloride to the dry component mixture; and (iii) combining the dry component mixture formed in step (ii) with water or an aqueous solution to form a topical composition.

[0133] In some embodiments, the composition comprises, based on the weight of the composition, 10% to 65% magnesium sulfate, 5% to 20% MSM, 5% to 35% magnesium chloride, 1% to 10% sodium bicarbonate, and / or 0.1% to 1% alpha-lipoic acid.

[0134] In some embodiments, the mixture formed in step (ii) comprises, based on the dry weight of the composition, 45% to 55% magnesium sulfate, 10% to 20% MSM, 20% to 30% magnesium chloride, 1% to 10% sodium bicarbonate, and 0.1% to 1% alpha-lipoic acid.

[0135] In some embodiments, the pharmaceutical composition comprises, based on the weight of the composition, 20% to 50% magnesium chloride, alpha-lipoic acid, sodium bicarbonate, magnesium sulfate, and methylsulfonylmethane (MSM), and 50% to 80% by weight of water or aqueous solution.

[0136] In some embodiments, an aqueous solution is added, and the aqueous solution contains lemon extract. In some embodiments, the lemon extract is lemon juice.

[0137] In some embodiments, the method includes the step of adding an oil (for example, betel nut (Piper Betle) leaf oil).

[0138] In some embodiments, a surfactant (e.g., polysorbate 20) is added.

[0139] In some embodiments, a mixture of betel leaf oil and polysorbate 20 is added. The mixture of betel leaf oil and polysorbate 20 can be in a weight ratio of betel leaf oil to polysorbate 20 ranging from 2:1 to 6:1 and from 3:1 to 5:1. Typically, the ratio of betel leaf oil to polysorbate 20 is 4:1.

[0140] If desired, the compositions may be prepared simultaneously, for example, immediately before administration. For example, a kit or package containing containers having different components of the composition may be provided. For example, one or more containers containing dry / solid components may be provided, and one or more containers containing liquid / water-soluble components may be provided.

[0141] In some embodiments, a package or kit is provided that includes at least two containers, for example, a first container containing magnesium chloride, alpha-lipoic acid and / or MSM, and a second container containing an aqueous solvent (e.g., lemon juice). In some embodiments, a further container containing sodium bicarbonate and magnesium sulfate is provided. In some embodiments, a further container containing betel nut leaf oil and polysorbate 20 is provided.

[0142] Any suitable container, such as a pouch, capsule, pack, or other similar form, may be used, along with instructions for dissolving / suspending the dry components in a suitable aqueous solvent such as water before topical application. The dry components may be combined into a single container, or the combined components or individual components may be provided in separate containers. The patient may be provided with a container of an aqueous solvent for mixing the dry components, such as buffered sterile water.

[0143] Therapeutic use The compositions described herein can be used for the treatment, prevention, and / or reduction of the severity of viral diseases and / or skin diseases.

[0144] Without being bound by any theory, the compositions of the present invention are thought to be effective in one or more of the following: i) inactivating, stopping, and / or inhibiting the progression of a virus; ii) promoting the efficacy of the body's healing processes and / or immune system processes; and iii) alleviating symptoms such as pain-related symptoms appearing on the skin and / or including neuropathic pain.

[0145] Examples of diseases for which the composition is found to be useful in treatment include herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis, and SARS-CoV-2.

[0146] Examples of symptoms for which the composition is found to be useful in treatment include cracked skin, skin bleeding, skin peeling, skin redness, and pain, including neuropathic pain.

[0147] Examples of diseases in which the composition is found to be useful in treatment are diseases caused by or associated with the varicella-zoster virus and / or viral skin diseases. Examples of such diseases include herpes zoster and varicella (also known as chickenpox) and / or neuropathy associated with such diseases. In one embodiment, the disease is herpes zoster. In a further embodiment, the disease is a part of herpes zoster, such as ocular herpes zoster.

[0148] The appearance of herpes zoster can be associated with COVID-19. There have been reports of COVID-19 patients suffering from herpes zoster. Furthermore, the compositions according to this disclosure have been found to have antiviral activity against the COVID-19 virus. Therefore, in some embodiments, the compositions are found to be useful in the treatment and / or prevention of skin diseases associated with SARS-CoV-2 and / or SARS-CoV-2 and in the treatment and / or prevention of herpes zoster associated with SARS-CoV-2.

[0149] In some embodiments, the composition finds use in the treatment and / or prevention of herpes simplex infection or diseases or disorders associated with herpes simplex infection. In some embodiments, the disease or disorder is herpes simplex type 1 infection or diseases or disorders associated with herpes simplex type 1 infection. In some embodiments, the disease or disorder is herpes simplex type 2 infection or diseases or disorders associated with herpes simplex type 2 infection. In some embodiments, the disease or disorder is oral herpes or genital herpes.

[0150] The compositions of the present invention are useful in treating symptoms of skin diseases, including pain, redness, rash, swelling, lesions, abscesses, and pustules. Accordingly, in some embodiments, the compositions are used for the prevention and / or treatment of at least one sign or symptom of a skin disease. In some embodiments, the compositions are used for the prevention and / or treatment of at least one sign or symptom of a skin disease selected from the group consisting of pain, redness, rash, swelling, lesions, abscesses, and pustules.

[0151] To treat and prevent skin diseases, the composition is usually applied topically to the affected skin as needed, for example, once a week or more, or for example, once a day or more. In one embodiment, the composition is applied to the skin once a day or more for a period of several days to several weeks until the signs or symptoms of the skin disease stabilize (stop progressing) or improve.

[0152] In one embodiment, the compositions described herein are applied topically by spraying onto the skin. The compositions may be stored in a refrigerator when not in use, if desired, and shaken well before use, for example. The compositions may then be sprayed onto the tissue to be treated or applied by hand. Typically, the compositions are applied once daily to the skin to be treated, but multiple daily applications of the compositions are permissible and safe. In some embodiments, the topical compositions are applied once daily in the evening, just before going to bed.

[0153] In some embodiments, the composition is administered by inhalation. For example, the composition may be diluted with warm water and its vapor may be inhaled.

[0154] The exact amount applied will vary depending on the disease being treated and the site of the onset, but if the composition is administered daily, the amount administered may be, for example, in the range of 0.5g to 100g per day or 2g to 25g per day, or approximately 0.5g, 1g, 2g, 3g, 4g, 5g, 6g, 7g, 9g, 10g, 15g, 20g, 25g, 30g, 40g, 50g, 60g, 70g, 80g, 90g, or 100g per day. The daily amount may be administered as a single dose or in repeated doses (for example, the composition may be administered two, three, four times or more times per day).

[0155] As is understood in the art, the composition may be used in combination with other well-known therapeutic agents that are considered clinically appropriate for the treatment of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis, and SARS-CoV-2.

[0156] The present invention will be described hereafter with reference to the following non-limiting embodiments. [Examples]

[0157] Examples Example 1. Formulation of topical composition The inventors of the present invention have formulated topical compositions for testing in trials for the treatment of severe acne vulgaris, sweat gland abscesses, and psoriasis. The formulations of the compositions for testing are provided in Table 1.

[0158] [Table 1]

[0159] The chemicals listed in Table 1 were combined by shaking vigorously for 3 minutes to ensure that all dry components, except for magnesium chloride and lemon extract juice, were completely mixed. Next, magnesium chloride was added and the composition was mixed. A 40 g sample of the mixed components was then dissolved in 100 ml of lemon extract juice and shaken for 4 minutes. When the topical composition was applied to a clean glass, it dried, leaving a powdery residue.

[0160] The topical composition was applied to the test subject's skin, particularly the arms, face, and neck, over a period of two weeks. Before use, the topical composition was shaken well and then sprayed onto the skin. After two weeks of treatment, there were no adverse reactions or side effects.

[0161] Example 1A. Formulation of topical composition The inventors of the present invention formulated further topical compositions for testing in the laboratory according to the formulations shown in Table 2.

[0162] [Table 2]

[0163] [Table 3]

[0164] To prepare the topical compositions according to Table 2, magnesium salt, dimethyl sulfone, and alpha-lipoic acid were dissolved in purified water. Glycerol was added while mixing until homogeneous. Xanthan gum was gradually added and mixed until well dispersed, but the batch had thickened at this point. Sodium bicarbonate was added and mixed until completely dissolved. The aqueous mixture was then heated to 70-75°C.

[0165] In separate reactors, the oil phase components (including Emulgade SE-PF and lanolin) were combined and heated to 70-75°C. The heated oil phase components were then added to the heated aqueous phase components, mixing until homogeneous. Mixing was then continued while the batch was cooled. Finally, Euxyl PE9010 and ethylhexylglycerin were mixed until the composition was homogeneous.

[0166] Example 2. Treatment of sweat gland abscess Patients with stage I sweat gland abscesses (HS) on the face and groin were treated with daily application of the topical compositions described herein for a period of three weeks. The topical composition of Example 1 was applied to the affected skin sites. After the three-week treatment period, patients reported a significant improvement in their HS. Figure 1 shows photographs of facial HS before and after treatment. As can be seen from the photographs in Figure 1, the signs and symptoms of HS significantly decreased after the three-week treatment period.

[0167] Example 3. Local treatment of herpes zoster Patients suffering from herpes zoster (shingles) and experiencing severe pain and discomfort were treated with the topical composition described herein. The composition was applied to the lesions twice daily. Redness and itching subsided within a short period after administration. Signs of viral infection disappeared within a few days. Treatment was continued for nine days. Figures 2A and 2B are photographs of the patients' legs taken before administration of the topical composition, showing the extent of infection and associated redness and lesions. Figures 2C and 2D are photographs of the patients' legs after three days of administration of the topical composition twice daily. As can be seen, the signs and symptoms of herpes zoster were significantly reduced.

[0168] Example 4: Local treatment of herpes zoster Patients suffering from herpes zoster with severe lesions were treated with the topical composition described herein. The affected areas were the posterior and anterior right neck, the anterior right shoulder, and the contour of the right mandible and ear. The composition was applied on day 0 to areas such as the head, hair, neck, and upper chest. After 2 hours, the patients reported a reduction in pus from the wounds and a decrease in pain and restriction of movement.

[0169] The composition was applied two more times on day 1 at 12-hour intervals.

[0170] On the sixth day, five days after the third treatment, the blister formation completely disappeared, leaving only scabs.

[0171] Figure 3A shows a photograph of the affected area of ​​the patient during the first treatment. Figure 3B shows a photograph of the affected area of ​​the patient five days after the third treatment.

[0172] Example 5. Herpes zoster - Inhalation therapy for ocular herpes zoster A female patient presented with symptoms of recurrent, severe headaches as a complication of herpes zoster. This disease originates in the ophthalmic branch of the trigeminal nerve and can lead to hemiplegic migraine and neuropathic pain. The patient had suffered from this disease for approximately 10 years. The patient was administered the composition defined herein.

[0173] Using microwaves, the composition was heated in a porcelain reactor in a solution of 50 mL of water and 30 mg of salt until it reached a steam-producing temperature. The reactor was partially covered with a towel, and the patient was instructed to inhale the steam deeply 10 times while breathing through their nose. This procedure was repeated twice daily, in the morning and evening, for three weeks. The patient noticed side effects such as a mild throbbing pain in the top of their head 1-2 hours after treatment.

[0174] Three weeks later, the patient noticed that they had not experienced any hemiplegic migraines during the course of treatment, which was the longest period without migraines in the patient's 10-year history. As a result of the reduced headaches, the patient chose to reduce their pain medication. In a follow-up interview conducted four months after the start of treatment, the patient stated that they were satisfied that their migraines or neurological symptoms had temporarily subsided without initiating any further treatment.

[0175] Example 6. Treatment of postherpetic neuralgia A female patient presented with symptoms of postherpetic neuralgia, a complication of herpes zoster. This condition affects nerve fibers and skin, often causing burning pain. The patient had suffered from this condition for approximately two and a half years. After administration of the topical composition described herein, the patient reported instantaneous relief from the burning pain. The patient reported that the pain returned after a short time, but after re-administering the composition, the burning sensation subsided, and she was able to continue normal activities. In particular, the patient reported that she could now lift and twist her mid-torso (the affected area) while performing physically demanding chores as part of her normal daily work.

[0176] The patient continued to receive the composition as needed over a period of several months and reported no longer experiencing burning pain or other symptoms associated with postherpetic neuralgia.

[0177] The patient reported experiencing no side effects.

[0178] Example 7: Treatment of pulmonary fibrosis The compositions defined herein were administered to patients suffering from pulmonary fibrosis, as well as those with coughing and reduced exercise capacity due to insufficient lung volume.

[0179] Using microwaves, the composition was heated in a porcelain reactor in a solution of 50 mL of water and 30 mg of salt until it reached a steam-producing temperature. The reactor was partially covered with a towel, and steam was introduced 28 times into the patient's open mouth while they breathed. This procedure was repeated twice daily for three weeks.

[0180] Three weeks later, it was noted that the severity of the cough had decreased significantly. The patient also reported that their voice had become noticeably stronger and that they were more mobile, which is thought to be due to an increase in lung volume. The patient had become physically stronger.

[0181] Example 8: Treatment of idiopathic pulmonary fibrosis Patients suffering from idiopathic pulmonary fibrosis were treated with compositions as defined herein.

[0182] The composition was administered via vapor inhalation treatment.

[0183] Using microwaves, the composition was heated in a 50 mL solution of water and 30 mg of salt in a reactor until it reached a steam-producing temperature. The reactor was partially covered with a towel, and steam was blown into the patient's open mouth several times while they breathed. This procedure was repeated twice daily for approximately two months.

[0184] The patient improved dramatically during that period and subsequently stopped treatment. Because the patient felt good, they did not feel the need for further use.

[0185] The patient went back to the clinician in charge of his case four months later for his annual check-up. The doctor was surprised to find that his medical condition had entered remission and that the patient was now strong enough to participate as a candidate in a lung transplant program.

[0186] One week later, the patient underwent a lung scan at the hospital. It was noted that the lungs were stable, further solidifying the indication that the disease had entered remission.

[0187] The patient has a stable lung volume of 120%, and is expected to receive a transplant in the future if an organ becomes available. The patient is enjoying a normal life.

[0188] Example 9: Treatment of atopic dermatitis A patient who had suffered from severe atopic dermatitis of the hands for more than 20 years, along with severe exudation and bleeding of the hands, was treated with the composition described herein. Before treatment, the patient's hands were severely cut, with large flap of skin hanging down from the center of the palms. Each finger had visible open cuts from which blood was oozing.

[0189] The formulation was administered topically to the patient's hand, and a photograph of the hand was taken the following day (see Figure 4). By this time, the swelling, redness, and pain had significantly decreased, the exudation had stopped, and the cracks had closed.

[0190] The treatment continued for several weeks, and the patient showed complete recovery from atopic dermatitis.

[0191] Example 10: In vitro test - Herpes simplex type 1 Samples of the formulations described in Example 1 were tested in vitro for virucidal activity against herpes simplex virus type 1. Virucidal testing using a carrier method was performed using protocol: TMCV 006, ASTM E1053. The test conditions were as follows:

[0192] [Table 4]

[0193] The table below shows the virus killing results after 30 seconds of contact for various virus dilution ratios.

[0194] [Table 5]

[0195] Conclusion: The formulation demonstrated virucidal activity against herpes simplex virus type 1 by achieving a 6.83 log reduction in viral concentration after a 30-second exposure period at room temperature.

[0196] Example 11: In vitro test - Herpes simplex type 2 Samples of the formulations described in Example 1 were tested in vitro for virucidal activity against herpes simplex virus type 2. Virucidal testing using a carrier method was performed using protocol TMCV 006, ASTM E1053. The test conditions were as follows:

[0197] [Table 6]

[0198] The table below shows the virus killing results after 30 seconds of contact for various virus dilution ratios.

[0199] [Table 7]

[0200] Conclusion: The formulation demonstrated virucidal activity against herpes simplex type 1 by achieving a 5.0 log reduction in viral concentration after a 30-second exposure period at room temperature.

[0201] Example 10. In vitro test - Mouse hepatitis virus (MHV1) Samples of the formulations described in Example 1 were tested in vitro for virucidal activity against mouse hepatitis virus (MHV1). Virucidal testing using a carrier method was performed using protocol TMCV 006, ASTM E1053. The test conditions were as follows:

[0202] [Table 8]

[0203] The table below shows the virus killing results after 30 seconds of contact for various virus dilution ratios.

[0204] [Table 9]

[0205] Conclusion: The formulation demonstrated virucidal activity against mouse hepatitis virus (MHV1) by achieving a 3.83 log reduction in viral concentration after a 30-second exposure period at room temperature.

[0206] Example 12: Clinical trial to determine the safety and efficacy of a topical composition in patients with mild to moderate sweat gland abscesses. In patients with mild to moderate sweat gland abscesses (defined by Hurley stage I or II), studies were conducted over an 8-week treatment period to determine the safety and efficacy of the topical compositions described herein.

[0207] the purpose: Main: • To determine the safety and efficacy of the composition solution when used twice daily for the treatment of mild to moderate sweat gland abscesses (defined by Hurley stage I or II) over an 8-week treatment period. Secondary: To determine the efficacy and effect on dermatological quality of life in participants who apply the composition twice daily over an 8-week treatment period for mild to moderate sweat gland abscesses (defined as Hurley stage I or II).

[0208] Method: This was an open-label pilot study enrolling up to 20 participants with mild to moderate sweat gland abscesses (Hurley stage I or II). All participants enrolled in the study received the active drug composition.

[0209] Participants were allowed to continue using regular medications, including non-topic HS treatment, during the trial, but any topical treatments or washes were discontinued before the start of the study treatment and not resumed until after week 8 of the trial or after its conclusion. There was no break period for discontinuing topical treatments.

[0210] The study drug was applied to all HS lesions twice daily for an 8-week period. Participants stopped treatment at week 8 and were followed up at week 10.

[0211] Clinic visits for participants were scheduled for screening / baseline, week 4, week 8, and week 10.

[0212] Participants were also followed up by telephone on day 7 (±3) after their screening / baseline visit.

[0213] The clinical assessment of efficacy was made and evaluated by the principal investigator based on a comparison of the patient's examination and photographs taken at previous visits. In addition, participants kept a diary at home and completed questionnaires at each clinic visit.

[0214] Reactions at the application site, such as dryness, heat, and pain, were assessed at the screening / baseline visit and at all subsequent visits.

[0215] participants Actual result: A total of 19 participants were screened and enrolled in the trial. Analysis: 19 participants were included in the largest analysis population, and 13 participants were included in the analysis population that met the clinical trial protocol criteria.

[0216] Diagnostic and main inclusion criteria: Participants were men or women aged 18 years or older with mild to moderate sweat gland abscesses (Hurley stage I or II) and at least one lesion in at least one clearly defined anatomical location.

[0217] Investigational drug, dosage, and mode of administration: The composition is given as two packets of powder with a total net weight of 30 g. Powder mix A contains the following active ingredients: Magnesium sulfate heptahydrate (15.31g) Magnesium chloride hexahydrate (7.85g) • Dimethyl sulfone (4.71g) Alpha-lipoic acid (0.16g) Powder B contains an inert ingredient: Sodium bicarbonate

[0218] Add bottled water to the combined powder to make a 50 mL solution, which can be stored at room temperature (<30°C) and used for up to 7 days.

[0219] A small amount of the solution was applied to all HS lesions once in the morning and again before bedtime. Participants were advised to allow the solution to dry on each HS lesion and not wash it off.

[0220] Duration of treatment: The treatment lasted for 8 weeks, followed by a 2-week follow-up period.

[0221] Judgment criteria: Safety: Safety was measured using the following key endpoints: • Incidence of adverse events (AEs) and serious AEs (SAEs) under the investigational treatment. Effectiveness: Efficacy was measured using the following primary endpoints: • Percentage of participants showing improvement in the physician's overall assessment (PGA) of HS. Efficacy was also measured using the following secondary endpoints: • Change from baseline in participants' modified Sartorius scores at weeks 4, 8, and 10. • Change from baseline in the total number of abscesses and inflammatory nodules in participants at weeks 4, 8, and 10. • Percentage of participants achieving clinical efficacy as measured by the High School of Science Clinical Response (HiSCR) at weeks 4, 8, and 10. Clinical efficacy is defined as a reduction of at least 50% from baseline in the total number of abscesses and inflammatory nodules (ANs), and no increase in the total number of abscesses from baseline. • The percentage of participants who experienced improvement in the Dermatology Life Quality Index (DLQI) from baseline to weeks 4, 8, and 10. • Mean change from baseline in Visual Analog Scale (VAS) pain scores at weeks 4, 8, and 10. • Percentage of participants experiencing improvement from baseline on hospital anxiety and depression scales at weeks 4, 8, and 10.

[0222] Summary - Conclusion Nineteen potential participants were screened, and all 19 were enrolled in the study and included in the FAS population. Thirteen participants were included in the PP population, and six participants were excluded because they did not have results at week 8. The ages of the study participants ranged from 18 to 43 years, with a mean of 30.9 years. There were 3 males (15.8%) and 16 females (84.2%). Most participants were Caucasian (n=17, 89.5%). Regarding the Hurley clinical staging classification, 9 participants (47.4%) had stage I HS, and 10 participants (52.6%) had stage II HS.

[0223] Safety results: A total of 13 out of 19 participants (68.4%) experienced 49 adverse events (AEs). All AEs were adverse events under the study treatment (TEAEs). The majority of AEs were mild (35 AEs) or moderate (12 AEs), with only 2 being severe. The number of participants who experienced at least one mild, moderate, or severe AE was 12 (63.2%), 5 (26.3%), and 1 (5.3%), respectively. There were no life-threatening or fatal AEs. There was one serious adverse event (SAE), but this was considered unrelated to the interstitial pneumonia (IP). There were no discontinuations due to IP.

[0224] Of the 19 participants, a total of 5 (26.3%) experienced 7 mild adverse events (AEs) that were considered to be potentially related to IP. The basic vocabulary (PT) for these adverse events was pain at the application site (n=2), itching at the application site (n=2), irritation at the application site (n=1), itching (n=1), and rash (n=1).

[0225] Overall, the composition was deemed safe and well-tolerated.

[0226] Results of effectiveness: Regarding the primary efficacy endpoint, compared to baseline, a total of 6 out of 13 participants (46.2%) showed improvement in their HS-PGA scores at week 4, 5 participants (38.5%) showed improvement at week 8, and 6 participants (46.2%) showed improvement at week 10.

[0227] Regarding secondary efficacy endpoints: Compared to baseline, 7 out of 13 participants (53.8%) demonstrated a decrease (improvement) in their modified Sartorius score for HS (HSMSS) at week 4, 8 participants (61.5%) demonstrated an improvement in HSMSS at week 8, and 7 participants (53.8%) demonstrated an improvement in HSMSS at week 10. Six of the 13 participants (46.2%) showed improvement in the total number of abscesses and inflammatory nodules (ANs) at weeks 4, 8, and 10 compared to baseline, although the individuals were not the same person at each week. Of the 13 participants, 6 (46.2%) had a high-level clinical response (HiSCR) at week 4, 5 (38.5%) at week 8, and 6 (46.2%) at week 10. Nine out of 13 participants (69.2%) experienced improvement in their Dermatology Life Quality Index (DLQI) scores at weeks 4, 8, and 10 compared to baseline. Notably, participants who did not show improvement in the sum of HS-PGA, HS-MSS, or AN scores still showed improvement in their DLQI scores. • When examining the mean change in total VAS score for pain at weeks 4, 8, and 10 compared to baseline, a decrease (i.e., improvement) was observed at each visit: mean 7.3 mm (SD=28.12) at week 4, mean 4.0 mm (SD=24.54) at week 8, and mean 6.4 mm (SD=15.79) at week 10. Compared to baseline, a total of 9 out of 13 participants (69.2%) experienced improvement in their VAS score at week 4, 6 participants (46.2%) experienced improvement at week 8, and 8 participants (61.5%) experienced improvement at week 10. HADS anxiety scores showed improvement in 3 out of 13 participants (23.1%) at week 4 compared to baseline, and in 9 participants (69.2%) at both weeks 8 and 10. HADS depression scores showed improvement in 4 out of 13 participants (30.8%) at week 4 compared to baseline, and in 6 participants (46.2%) at both weeks 8 and 10.

[0228] conclusion When examining individual responses, a total of 6 out of 13 participants (46.2%) demonstrated improvement in HS-PGA compared to baseline at week 4, 5 out of 13 participants (38.5%) at week 8, and 6 out of 10 participants (46.2%) at week 10. Compared to baseline, a further 7 out of 13 participants (53.8%) showed no change in their HS-PGA score at week 4, 7 out of 13 participants (53.8%) showed no change at week 8, and 6 out of 13 participants (46.2%) showed no change at week 10. No participants had a worse HS-PGA score at week 4, and only 1 participant (7.7%) had a worse HS-PGA score at both week 8 and week 10.

[0229] Participants who demonstrated improvement in HS-PGA compared to baseline generally showed consistent improvements across multiple efficacy variables, including a decrease in the total number of ANs from baseline, improvements in total HS clinical effect (HiSCR), and improvements in HS-MSS. Most of these participants also showed improvements in DLQI and VAS scores at the corresponding time points compared to baseline. Since none of the participants resumed topical HS medication between weeks 8 and 10, it can be said that participants who showed improvement in measurements at week 10 compared to baseline were able to do so despite discontinuing IP and other topical HS treatments for two weeks.

[0230] The overall safety and tolerability results of Hidracare, as well as the promising primary and secondary efficacy results, support further research of Hidracare, including larger Phase II trials.

[0231] It will be understood by those skilled in the art that numerous modifications and / or modifications can be made to the invention as shown in particular embodiments without departing from the broadly described scope of the invention. This embodiment should therefore be considered in all respects as illustrative and not limiting.

[0232] All publications described and / or referenced herein are incorporated herein in their entirety.

[0233] Any description of documents, acts, materials, apparatus, articles, or other similar matters contained herein is solely for the purpose of providing background to the invention. It should not be construed as granting permission that any or all of these matters constitute part of the foundation of the prior art or are general knowledge in the art relating to the invention, and that they existed prior to the priority date of any claim of this application.

Claims

1. A pharmaceutical composition containing the following: (a) Magnesium salts and (b) Lipoic acid and / or methylsulfonylmethane (MSM).

2. The pharmaceutical composition according to claim 1, wherein the magnesium salt is selected from the group consisting of magnesium chloride and magnesium sulfate.

3. The pharmaceutical composition according to claim 1 or 2, wherein the composition is formulated for topical administration.

4. The pharmaceutical composition according to any one of claims 1 to 3, comprising magnesium chloride, alpha-lipoic acid, and methylsulfonylmethane (MSM).

5. The pharmaceutical composition according to any one of claims 1 to 4, further comprising sodium bicarbonate.

6. The pharmaceutical composition according to any one of claims 1 to 5, wherein the composition is in the form of a liquid, aqueous solution, gel, suspension, emulsion, ointment, or cream.

7. The pharmaceutical composition according to any one of claims 1 to 6, wherein the composition comprises, based on the weight of the composition, 10% to 65% magnesium sulfate, 5% to 20% MSM, 5% to 35% magnesium chloride, 1% to 10% sodium bicarbonate and / or 0.1% to 1% alpha-lipoic acid.

8. The pharmaceutical composition according to any one of claims 1 to 7, wherein the composition comprises 20% to 50% by weight of the composition, consisting of magnesium chloride, alpha-lipoic acid, sodium bicarbonate, magnesium sulfate, and methylsulfonylmethane (MSM).

9. The composition is a pharmaceutical composition according to any one of claims 1 to 8, comprising lemon extract.

10. The pharmaceutical composition according to any one of claims 1 to 9, comprising 50% to 80% by weight of lemon extract.

11. The pharmaceutical composition according to any one of claims 1 to 10, comprising a skin emollient, a wetting agent, an emulsifier, or a preservative, or a mixture thereof.

12. i) The skin emollient is selected from the group consisting of glyceryl stearate, ceteareth-20, ceteareth-12, cetearyl alcohol, cetyl palmitate, dimethicone, cyclopentasiloxane, cyclohexasiloxane, and caprylic / capric triglyceride or mixtures thereof; ii) The wetting agent is selected from the group consisting of glycerol, glycerin, salicylic acid, and sorbitol or mixtures thereof; ii) The emulsifier is selected from the group consisting of glyceryl stearate, ceteareth-20, ceteareth-12, cetearyl alcohol, and cetyl palmitate or mixtures thereof; and iii) The pharmaceutical composition according to claim 11, wherein the preservative is selected from the group consisting of phenoxyethanol, ethylhexylglycerin, sodium benzoate, or a mixture thereof.

13. A method for treating, preventing, or reducing the severity of a viral infection or a disease or disorder associated with a viral infection, or symptoms of a viral infection or symptoms of a disease or disorder associated with a viral infection, comprising administering an effective amount of the pharmaceutical composition described in any one of claims 1 to 12 to the subject.

14. The method according to claim 13, wherein the aforementioned viral infection or disease or disorder related to a viral infection is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, and SARS-CoV-2.

15. The method according to claim 13, wherein the symptoms are selected from the group consisting of cracked skin, skin bleeding, skin peeling, skin redness, and pain.

16. A method for treating, preventing, or reducing the severity of a disease or disorder or its symptoms in a subject, wherein the disease or disorder is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis, and SARS-CoV-2, and the method comprises administering an effective amount of the pharmaceutical composition described in any one of claims 1 to 12 to the subject.

17. The method according to any one of claims 13 to 16, wherein the composition is administered topically to the subject.

18. The method according to any one of claims 13 to 17, wherein the composition is applied to the target skin once, twice, or three times a day.

19. The method according to claim 18, wherein the topical composition is applied once a day.

20. The method according to any one of claims 13 to 19, wherein the composition is applied as a spray, cream, or liquid.

21. The method according to any one of claims 13 to 16, wherein the composition is administered to the subject by inhalation.

22. Use of the pharmaceutical composition according to any one of claims 1 to 12 for the manufacture of a pharmaceutical for treating, preventing, or reducing the severity of a viral infection or a disease or disorder associated with a viral infection, or symptoms of a viral infection or symptoms of a disease or disorder associated with a viral infection.

23. The use according to claim 22, wherein the aforementioned viral infection or disease or disorder associated with a viral infection is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, and SARS-CoV-2.

24. The use according to claim 22, wherein the symptoms are selected from the group consisting of cracked skin, skin bleeding, skin peeling, skin redness, and pain.

25. Use of a pharmaceutical composition according to any one of claims 1 to 12 for the manufacture of a medicament for treating, preventing or reducing the severity of a disease or disorder or the symptoms of a disease or disorder, wherein the disease or disorder is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis, and SARS-CoV-2.

26. The composition is administered topically, as described in any one of claims 22 to 25.

27. The use according to any one of claims 22 to 26, wherein the composition is applied to the target skin once, twice, or three times a day.

28. The use according to claim 27, wherein the topical composition is applied once a day.

29. The use of the composition according to any one of claims 22 to 28, wherein the composition is applied as a spray, cream, or liquid.

30. The use according to any one of claims 22 to 25, wherein the composition is administered to the subject by inhalation.

31. A pharmaceutical composition according to any one of claims 1 to 12, for use in treating, preventing, or reducing the severity of a viral infection or a disease or disorder associated with a viral infection, or symptoms of a viral infection or symptoms of a disease or disorder associated with a viral infection.

32. The pharmaceutical composition for use according to claim 31, wherein the aforementioned viral infection or disease or disorder related to a viral infection is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, and SARS-CoV-2.

33. The pharmaceutical composition for use according to claim 31, wherein the symptoms are selected from the group consisting of cracked skin, skin bleeding, skin peeling, skin redness, and pain.

34. A pharmaceutical composition according to any one of claims 1 to 12 for use in treating, preventing or reducing the severity of a disease or disorder or the symptoms of a disease or disorder, wherein the disease or disorder is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis, and SARS-CoV-2.

35. The composition is a pharmaceutical composition for use according to any one of claims 31 to 34, which is administered topically.

36. The composition is a pharmaceutical composition for use according to any one of claims 31 to 35, which is applied to the target skin once, twice, or three times a day.

37. The topical composition is a pharmaceutical composition for use according to claim 36, which is applied once a day.

38. The composition is a pharmaceutical composition for use according to any one of claims 31 to 37, which is applied as a spray, cream, or liquid.

39. The use according to any one of claims 31 to 34, wherein the composition is administered to the subject by inhalation.

40. A pharmaceutical composition according to any one of claims 1 to 12, used to treat, prevent, or reduce the severity of a viral infection or a disease or disorder associated with a viral infection, or symptoms of a viral infection or symptoms of a disease or disorder associated with a viral infection.

41. The aforementioned viral infection or disease or disorder related to a viral infection is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, and SARS-CoV-2, and is a pharmaceutical composition used in accordance with claim 40.

42. The aforementioned symptoms are selected from the group consisting of cracked skin, skin bleeding, skin peeling, skin redness, and pain, as a pharmaceutical composition used in accordance with claim 40.

43. A pharmaceutical composition according to any one of claims 1 to 12, for use in treating, preventing or reducing the severity of a disease or disorder or its symptoms, wherein the disease or disorder is selected from the group consisting of herpes zoster infection, varicella-zoster infection, herpes simplex infection, varicella, herpes zoster, oral herpes, genital herpes, sweat gland abscess, psoriasis, acne, atopic dermatitis, atopic eczema, postherpetic neuralgia, pulmonary fibrosis, and SARS-CoV-2.

44. The composition is a pharmaceutical composition to be administered topically and used in accordance with any one of claims 40 to 43.

45. The composition is a pharmaceutical composition used in accordance with any one of claims 40 to 44, applied to the target skin once, twice, or three times daily.

46. The topical composition is a pharmaceutical composition used in accordance with claim 45, which is applied once a day.

47. The composition is a pharmaceutical composition used in accordance with any one of claims 40 to 46, applied as a spray, cream, or liquid.

48. The composition is a pharmaceutical composition used in accordance with any one of claims 40 to 43, administered to the subject by inhalation.

49. A method for preparing a pharmaceutical composition according to any one of claims 1 to 12, Combining methylsulfonylmethane (MSM) and / or alpha-lipoic acid with magnesium salts to form a mixture, and A method comprising combining the aforementioned mixture with water or an aqueous solution.

50. The aforementioned method, (i) Combining magnesium sulfate, methylsulfonylmethane (MSM), alpha-lipoic acid, and sodium bicarbonate, (ii) Add magnesium chloride to the product of step (i) in order to form a mixture. The method according to claim 47, comprising (iii) combining the mixture formed in step (ii) with water or an aqueous solution.

51. The method according to claim 50, wherein the mixture formed in step (ii) comprises, based on the weight of the composition, 10% to 55% magnesium sulfate, 5% to 20% MSM, 5% to 30% magnesium chloride, 1% to 10% sodium bicarbonate, and 0.1% to 1% alpha-lipoic acid.

52. The method according to any one of claims 49 to 51, wherein the pharmaceutical composition comprises, based on the weight of the composition, 20% to 50% magnesium chloride, alpha-lipoic acid, sodium bicarbonate, magnesium sulfate, and methylsulfonylmethane (MSM), and 50% to 80% by weight of water or an aqueous solution.

53. The method according to any one of claims 49 to 52, wherein an aqueous solution is added, the aqueous solution comprising lemon extract.

54. The method according to claim 53, wherein the lemon extract is lemon juice.

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